FDA.reportPublic FDA data

Major Regular Strength

Product NDC
0904-6412
11-digit product format
009046412
Labeler code
0904
Product ID
0904-6412_3f259abe-0583-b413-e063-6394a90ad720
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-12
Substance
CALCIUM CARBONATE
Active strength
500 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Major Regular Strength
Brand name suffix
Assorted Flavors
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui308907

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6412-92Major Regular StrengthAssorted Flavors150 in 1 BOTTLE, PLASTICTABLET, CHEWABLE15010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6412-92EA - Each0904-6412bb975321-582f-4b0a-b5a6-7010bc851aaa12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6412MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20241024_2ba0eeb2-7048-4259-83d5-9f4ec1c92d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN2ba0eeb2-7048-4259-83d5-9f4ec1c92d3210
308907calcium carbonate 500 MG Chewable TabletSCD2ba0eeb2-7048-4259-83d5-9f4ec1c92d3210
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY2ba0eeb2-7048-4259-83d5-9f4ec1c92d3210
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSNaf10dfb6-fef3-3410-e053-2995a90a91303
308907calcium carbonate 500 MG Chewable TabletSCDaf10dfb6-fef3-3410-e053-2995a90a91303
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSYaf10dfb6-fef3-3410-e053-2995a90a91303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6412-9200904641292150 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0904-6412-92) 2014-08-120000-00-00NoNoCurrent